Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays

The three purposes of this study are: 1) to compare the effects on looking behaviors, visual fixation and social interaction through the use of a head- mounted, eye-tracker in toddlers with motor disabilities after receiving different intensity levels of ROC-Stand training; 2) to compare short-term and long-term outcomes in terms of body function, activity and participation across the ICF framework, family perceptions and participation; and 3) to identify factors that predict individual differences in outcomes for toddlers with motor delays with the two dosing protocols. Based on the power analysis from the pilot study, the investigators will recruit 30 toddlers with motor delays and further randomly assign the participants to the 3 groups with the same total amount of 48-hour training, including 2 ROC-Stand groups and 1 conventional therapy group, i.e., an intensity level of 2-hour session of ROC-Stand training (ROC-Stand(2-hr)) (n=10), an intensity level of 1-hour session of ROC-Stand training (ROC-Stand(1-hr)) (n=10), and an intensity level of 1-hour session of conventional therapy (Control(1-hr)) (n=10). The training frequency for the 3 groups is 2 sessions/per week. The whole study duration will be 1 year. The head-mounted cameras worn by the participants will record the visual and interactive behaviors for 20 minutes/per week during intervention. Standardized assessments are provided for a total 4 times, including the time before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4). Assessments include body function, activity and participation across the ICF domains, family perception and participation. The findings of this study will provide guidelines for adjusting the dosage parameters of early powered mobility depending on each child's and family's needs.

NCT Number	NCT06000631
Lead Sponsor	Chang Gung Memorial Hospital
Conditions	Young Children With Motor Disabilities
Enrollment	30 participants
Start Date	2023-08-30
Primary Completion	2025-11-30 (estimated)
Study Completion	2026-07-31 (estimated)
Updated on ClinicalTrials.gov	2024-01-11